MAUDE Adverse Event Report: GYRUS ACMI, INC CUTTING LOOP (12/PK)

Model Number MLE-24-012

Device Problems Break (1069); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that during a ¿dilation and curettage hysteroscopy with myomectomy¿ procedure, the right angle cutting loop electrode used found disappeared as if it disintegrated or burned off (as described) by the reporter.At the time of the event, the loop was being used at the 220 cut and 100 coagulation setting.Both the uterus and specimen were searched for any parts inside the patient.According to the reporter, the user (physician) was confident that nothing was left behind.The subject device was sent to user¿s material management for return to manufacturer.

Manufacturer Narrative

This supplemental report is being submitted to provide customer updates and response.Please see updated sections:b5, g4, g7, h2, h6 and h10.

Event Description

The procedure was completed with a backup similar device.There was a minimal delay to search for any retained piece and none found.The patient received a normal follow up.There was no adverse effects from the procedure and patient was discharged.There was no smoke observed during the malfunction reported.Staff performed a visual inspection during preparation for the procedure.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.No device was made available to olympus for evaluation therefore no definitive root cause could be determined.Dhrs (device history records) could not be reviewed as the lot number remains unknown.The reported failure may have been attributable to a malfunction of the electrosurgical generator, a device collision or use of excessive output energy.Information regarding model of generator was not provided nor was the generator or other accessories returned to olympus for evaluation.The device ifu (instruction for use)(98-1082 rev be) instructs the following, "study this manual and other labeling thoroughly for safe handling, storage and usage, including instructions for all generators and accessories.Ensure that all components to be used are compatible for use with each other according to these instructions and the instructions for use for the other components to be used.Failure to properly follow the instructions, warnings, and cautions may lead to serious surgical consequences or injury to the patient and/or surgical team.Misuse of instruments can cause injury to the patient and/or surgical team and could have an adverse effect on the procedure being performed.Do not drop instruments, or allow them to be struck by other objects.Prior to increasing any power settings, recheck all cables, connections, patient contacts, and irrigation fluid before proceeding.Once this is done, the power may be gradually increased.Note the tissue effect after each increase.Olympus will continue to monitor complaints for this device.

• Brand Name: CUTTING LOOP (12/PK)
• Type of Device: CUTTING LOOP (12/PK)
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10677306
• MDR Text Key: 213264350
• Report Number: 3011050570-2020-00104
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• PMA/PMN Number: K890328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MLE-24-012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 10/21/2020; 01/29/2021
• Supplement Dates FDA Received: 11/03/2020; 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 27 YR
• Patient Weight: 74